FDA Label for Bedside-care
View Indications, Usage & Precautions
Bedside-care Product Label
The following document was submitted to the FDA by the labeler of this product Coloplast Manufacturing Us, Llc. The document includes published materials associated whith this product with the essential scientific information about this product as well as other prescribing information. Product labels may durg indications and usage, generic names, contraindications, active ingredients, strength dosage, routes of administration, appearance, warnings, inactive ingredients, etc.
Other
For Full Body Bathing and Perineal Clean-Up
Drug Facts
For external use only.
Otc - Active Ingredient
Active ingredient
Benzethonium Chloride 0.1%
Otc - Purpose
Purpose
Antiseptic
Indications & Usage
Uses Protects against the risk of bacterial contamination in minor cuts, scrapes and burns.
Warnings
Warnings
Otc - When Using
When using this product: do not use in the eyes, with deep or puncture wounds, serious burns or animal bites.
Otc - Stop Use
Stop using this product:
- if skin irritation and redness develop
- if condition persists for more than 72 hours, consult a physician.
Otc - Keep Out Of Reach Of Children
Keep this and all drugs out of the reach of children. If swallowed, get medical help or contact a Poison Control Center immediately.
Dosage & Administration
Directions Cleanse the affected area according to protocol.
Inactive Ingredient
Inactive ingredients water, sodium lauroamphoacetate, cocamidopropyl betaine, glycerin, polysorbate 20, quaternium-52, citric acid, quaternium-15, fragrance, tetrasodium EDTA, green 5
Protocol: Rinsing is not required. Aids in the removal of urine, feces and other foreign material. Bathing: dispense 3-4 sprays in a basin with warm water and cleanse the skin. Shampooing: spray directly on dampened hair, lather and remove with a mois washcloth. Cleansing: apply to the affected perineal area and remove with a moist washcloth.
Manufactured by: Coloplast A/S
DK-3050 Humlebaek, Denmark
Distributed by: Coloplast Corp.
Minneapolis, MN 55411 U.S.A.
1-800-533-0464 www.us.coloplast.com
Product #1762 ©2009-2, Coloplast Corp.
Made in the U.S.A.
B9-612
Package Label.Principal Display Panel
PRINCIPAL DISPLAY PANEL - 8 fl. oz. (237 mL)
NDC 11701-020-05
Bedside-Care®
No-Rinse Cleanser
No-Rinse Body Wash, Shampoo &-Incontinent Cleanser
For Full Body Bathing and Perineal Clean-Up
Coloplast
8 fl. oz. (237 mL)
* Please review the disclaimer below.
